The current study is intended to enrich and extend the database of Alzheimer's Disease (AD) and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. This study will include 2 MEG and electroencephalography (EEG) scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects will undergo 2 standard functional tests.

Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ consistently (e.g. at all evaluation time points) between HC and AD subjects [ Time Frame: approximately 30 days ] [ Designated as safety issue: No ]

Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ across time points within single subjects and across groups of HC and AD subjects [ Time Frame: Approximately 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identification and characterization of Orasi SNI test features that correlate with independent measures of cognitive function based on functional testing (ADAS-Cog sum of boxes, and MMSE raw score, One Card Learning Test) [ Time Frame: Approximately 30 days ] [ Designated as safety issue: No ]

Identification and characterization of Orasi SNI test features that correlate with AD medications being taken by AD subjects [ Time Frame: Approximately one month ] [ Designated as safety issue: No ]

Identification, characterization and comparison of scan results generated by MEG and EEG [ Time Frame: Approximately one month ] [ Designated as safety issue: No ]

This study is intended to extend the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under development by the sponsor, Orasi Medical, Inc. Magnetoencephalography (MEG) is an FDA-approved, non-invasive technique used to measure magnetic fields generated by small intracellular electrical currents in neurons. The SNI test evaluates brain function and dysfunction by analyzing brief (1 minute) MEG scans and comparing individual scan results to a database of MEG scans and clinical information. Proprietary software algorithms process the data generated by MEG instruments allowing Orasi to use the SNI test for accurate tracking and diagnosis of neurological disorders such as Alzheimer's disease (AD) and Multiple Sclerosis (MS). The current study is intended to enrich and extend the database of AD and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. This study will include 2 MEG and EEG scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects will undergo 2 standard functional tests. The results generated in this study will be used to improve the accuracy of the SNI test for diagnosing and tracking the progression of AD. Once a robust training set or template is described, Orasi Medical will conduct additional clinical studies to formally test the diagnostic accuracy of the technology and support applications for regulatory approval to market the SNI test for AD. The objective of this work is to produce and validate a novel tracking and diagnostic technology for AD that is more selective and sensitive than currently available diagnostic tools.

Eligibility

Ages Eligible for Study:

50 Years to 90 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Probability Sample

Study Population

The current study will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched healthy control subjects meeting criteria of normal neurological function.

Criteria

Inclusion Criteria:

Subject has been diagnosed with dementia of Alzheimer's type (DSM-IV-TR) or is serving as a healthy control subject with normal neurological function based on medical history and following neurological exam.

The subject has a recent history (within 2 years) of alcohol or substance abuse/dependence.

Subject had an MRI within two weeks prior to Study Day 1.

Subject has metal dental braces, pacemaker or other common medical devices that may interfere with the MEG scan.

Subject is unable to complete the MEG scan procedure.

Investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973518